K2M, Inc recalls Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

Recall date

September 8, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0104-2022

FDA classification

Class II

Brand / firm

K2M, Inc

Sold / distributed

Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.

Why it was recalled

Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068